As mentioned last month, drug pricing negotiations are now underway in Japan, in line with the Fiscal System’s Council guidance for the FY2026 budget. In contrast to the Japan Pharmaceutical Association’s desire for higher prices, the Japanese Ministry of Finance (MOF) is seeking a tougher stance on high-priced pharmaceuticals. The MOF recommended the maximum use of the cost-effectiveness assessment (CEA) system and simultaneously called for a pro-innovation pricing system. Also, after the initial pricing, future drug pricing decisions should be made only with strong clinical and economic data.
The MOF also warned that if high-priced medicines continue to increase, there will likely be many new drug approvals where the insurance is not adequate. Thus, the MOF recommended greater flexibility and expansion of the mixed billing system and an increased role for private insurance. In addition, the MOF recommended re-pricing more often than just every 2 years and increasing the number of drugs subject to re-pricing on a quarterly basis.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.